The following data is part of a premarket notification filed by Medrange with the FDA for Electrosurgical Generator And Accessories.
Device ID | K201224 |
510k Number | K201224 |
Device Name: | Electrosurgical Generator And Accessories |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | Medrange 480 Apollo Street, Suite D. Brea, CA 92821 |
Contact | Helen Xie |
Correspondent | Helen Xie Medrange 480 Apollo Street, Suite D. Brea, CA 92821 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-05-06 |
Decision Date | 2020-09-18 |